Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bortezomib together with cetuximab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 2, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Interventions being studied
- Biological: cetuximab; Drug: bortezomib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Diagnosis of solid tumor that overexpresses epidermal growth factor receptor (EGFR) including, but not limited to, the following:
- Breast cancer
- Lung cancer
- Colon cancer
- Pancreatic cancer
- Head and neck cancer
- Kidney cancer
- Sarcoma
- Advanced disease
- Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy
- Measurable or nonmeasurable disease
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 9 g/dL
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase \< 3.0 times ULN (5.0 times ULN if liver has tumor involvement)
- Aspartate aminotransferase (AST) and alanine aminotransferase (\*ALT) \< 3.0 times upper limit of normal (ULN) (5.0 times ULN if liver has tumor involvement)
- Creatinine clearance \> 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Recovered from all prior therapy
- Prior systemic chemotherapy, immunotherapy, or biological therapy allowed
- At least 14 days since prior radiotherapy or systemic therapy
- At least 30 days since prior investigational agents
- At least 14 days since other prior investigational drugs (for reasons other than the treatment of cancer)
- Untreated or symptomatic central nervous system (CNS) metastases
- Concurrent serious systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- Uncontrolled diabetes
- Myocardial infarction within the past 6 months
- New York Heart Association (NYHA) class III or IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Evidence of acute ischemia or active conduction system abnormalities by ECG
- Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade \> 2
- Known hypersensitivity to bortezomib, boron, or mannitol
- Serious medical or psychiatric illness likely to interfere with study participation
- Prior bortezomib and/or cetuximab
- Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 2, 2017. Always confirm current availability with the study team.